U.S. advisers back DNA-based colon cancer test
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A colon cancer screening method that analyzes DNA from stool samples won the unanimous backing of a U.S. advisory panel on Thursday, paving the way for potential regulatory approval of the non-invasive test.
A panel of outside experts advising the Food and Drug Administration voted 10-0 to recommend approval of the Cologuard screening test made by Exact Sciences Corp.
The company said a large clinical trial found that its test detected 92.3 percent of colorectal cancers in average-risk patients based on a combination of DNA and hemoglobin markers.
While a colonoscopy is considered the most accurate method of detecting colon cancer and polyps, many people avoid the test, which involves inserting a flexible tube into the colon.
If Cologuard is approved by the FDA, patients who have a positive cancer finding with the test, which identifies abnormal cells shed in the stool, would then undergo a colonoscopy.
The FDA usually follows panel recommendations, although it is not required to.
The American Cancer Society estimates about 50,000 deaths from colorectal cancer in the United States this year. It is the third leading cause of cancer-related deaths in the United States when men and women are considered separately, and the second leading cause when both sexes are combined.
Shares of Exact Sciences, which were halted on the Nasdaq on Thursday, were up 75 cents, or 5.5 percent at $14.50 in after-hours trading. The shares have gained more than 40 percent over the past 12 months.
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(Reuters)
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